PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates

Completed · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

Study 516-010 is an open-label Phase 1, drug-drug interaction and QTc study evaluating the effect of sitravatinib on probe substrates for CYP450 enzymes and BCRP and P-gp transporters.

Key facts

Study ID

NCT04887194

Run by

Mirati Therapeutics Inc.

People needed

40

Starts

2021-04-08

Expected to finish

2022-12-22

Last updated by the study team

2024-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of unresectable advanced/metastatic solid tumor
• Life expectancy of at least 3 months
• Adequate bone marrow and organ function

You may not qualify if…

• Ongoing medical condition or need for treatment with medication that may affect the PK of study treatments during Part 1
• Immunocompromising conditions
• Impaired heart function
• Active or prior documented autoimmune disease

Where it is running

• Goshen Health — Goshen, Indiana, United States
• NEXT Oncology — Austin, Texas, United States
• NEXT Oncology — San Antonio, Texas, United States
• NEXT Oncology — Fairfax, Virginia, United States
• MultiCare Health System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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